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Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1099
(978) 687-1501
Printed in USA
Document number
453 564 242 441
Warranty
The information contained in this document is subject to change without
notice. Philips Medical Systems makes no warranty of any kind with regard to
this material, including, but not limited to, the implied warranties or
merchantability and fitness for a particular purpose. Philips Medical Systems
shall not be liable for errors contained herein or for incidental or consequential
damages in connection with the furnishing, performance, or use of this
material.
ii
FCC
This device complies with Part 15 and/or Part 95 of the FCC Rules. Operation
is subject to the following two conditions: (1) these devices may not cause
harmful interference, and (2) these devices must accept any interference
received, including interference that may cause undesired operation.
Changes and modifications not expressly approved by Philips Medical
Systems can void your authority to operate this equipment under Federal
Communications Commission's rules
Printing History
New editions of this document will incorporate all material updated since the
previous edition. Update packages may be issued between editions and
contain replacement and additional pages to be merged by a revision date at
the bottom of the page. Note that pages which are rearranged due to changes
on a previous page are not considered revised.
The documentation printing date and part number indicate its current edition.
The printing date changes when a new edition is printed. (Minor corrections
and updates which are incorporated at reprint do not cause the date to
change.) The document part number changes when extensive technical
changes are incorporated.
First Edition June 2011
Document Conventions
In this guide:
Warnings
Warning
A Warning alerts you to a potential serious outcome, adverse event or safety
hazard. Failure to observe a warning may result in death or serious injury to
the user or patient.
iii
Cautions
Caution
A Caution alerts you to where special care is necessary for the safe and
effective use of the product. Failure to observe a caution may result in minor
or moderate personal injury or damage to the product or other property, and
possibly in a remote risk of more serious injury.
Notes
A Note contains additional information on the product's usage.
General Safety -------------------------------------------------------------------------- 2-2
Safety Symbols & Other Marks ----------------------------------------------------- 2-4
3. Basic Operation 3-1
Controls, Indicators and Connectors ---------------------------------------------- 3-2
MX40 Controls and Indicators -------------------------------------------------- 3-2
Operating and Navigating ------------------------------------------------------------ 3-8
Power-On Self Test --------------------------------------------------------------- 3-8
Navigating --------------------------------------------------------------------------- 3-8
Selecting Display Elements ----------------------------------------------------- 3-9
Locking the Display---------------------------------------------------------------- 3-9
Measurement Area ---------------------------------------------------------------- 3-9
Measurement Area Display Configurations -------------------------------- 3-10
Connecting/Disconnecting the Patient Cable ----------------------------- 3-10
Changing Measurement Settings --------------------------------------------- 3-12
ECG Settings at the MX40 ----------------------------------------------------- 3-12
Waveform Settings at the MX40 ---------------------------------------------- 3-13
Battery Information -------------------------------------------------------------------- 3-14
Battery Safety Information ------------------------------------------------------ 3-14
Lithium-ion Rechargeable Battery Care ------------------------------------ 3-15
Inserting/Removing Batteries -------------------------------------------------- 3-16
Inserting Batteries ---------------------------------------------------------------- 3-17
Removing the Batteries --------------------------------------------------------- 3-19
Battery Charge Status ----------------------------------------------------------- 3-20
ST/AR Arrhythmia Algorithm -------------------------------------------------- 5-23
How the ST/AR Algorithm Works -------------------------------------------- 5-23
ECG and Arrhythmia Alarm Overview -------------------------------------- 5-24
Using ECG Alarms --------------------------------------------------------------- 5-25
Learning ---------------------------------------------------------------------------- 5-27
Initiating Arrhythmia Relearning Manually --------------------------------- 5-29
ST/AR ST Analysis Algorithm ----------------------------------------------------- 5-30
Intended Use ---------------------------------------------------------------------- 5-30
The Measurement --------------------------------------------------------------- 5-31
Algorithm Processing ----------------------------------------------------------- 5-31
Displayed ST Data --------------------------------------------------------------- 5-32
Contents - 2
EASI ST Analysis ----------------------------------------------------------------- 5-32
Turning ST Monitoring On/Off ------------------------------------------------- 5-32
Intended Use ----------------------------------------------------------------------- 5-34
How the QT Analysis Algorithm Works ------------------------------------- 5-34
6. Monitoring Pulse Rate 6-1
Pulse Rate Measurement ------------------------------------------------------------ 6-2
Displaying the Pulse Rate Measurement at the MX40 ----------------------- 6-3
7. SpO2 Monitoring 7-1
SpO2 Safety Information -------------------------------------------------------------- 7-2
SpO2 Information for the User -------------------------------------------------- 7-4
Device Assignment at the Information Center ----------------------------- 8-3
Device Assignment at the MX40 ----------------------------------------------- 8-3
Device Assignment at the Patient Monitor ---------------------------------- 8-4
Controls Available when Assigned to IntelliVue Cableless Measurements8-6
Controls Available when Assigned to IntelliVue Patient Monitors --------- 8-7
Networked Device Synchronized Alarm Settings ------------------------------ 8-8
MX40 Display when Wirelessly Connected to a Patient Monitor ---------- 8-9
9. Monitoring with the MX40 at the Information Center 9-1
MX40 Connection to the Information Center ------------------------------------ 9-2
MX40 Controls in the Patient Window -------------------------------------------- 9-3
Locating the MX40 (Find Device) -------------------------------------------------- 9-5
Viewing Device Location and Location History (optional) ------------------- 9-6
Using the Device Location Client (optional) ------------------------------------- 9-7
Patient Configurable Settings in Telemetry Setup ----------------------------- 9-8
Unit Configurable Settings ---------------------------------------------------------- 9-11
10. Operating with Information Center Release L or M 10-1
Cleaning Materials for the MX40 --------------------------------------------- 12-2
Disposing of the MX40 -------------------------------------------------------------- 12-4
Label Assignment for Replacement MX40 ------------------------------------- 12-5
Re-assigning an Equipment Label ------------------------------------------ 12-5
This section introduces the IntelliVue MX40 wearable patient monitor.
Introducing the IntelliVue MX40 1-1
MX40 Features
Easy for clinicians to use and comfortable for patients to wear.
2.8" color, touch sensitive display. Smart, multi-measurement cable system available for use with reusable
and single-patient use supplies.
FAST SpO2 (continuous, or manual measurement). EASI or standard ECG selectable in one device. 6-lead with two V-leads for diagnosing multiple cardiac abnormalities,
including wide-QRS complex tachycardias and acute myocardial
ischemia/infarction.
Local measurement trend/alarm history. Local alarming for measurements (requires IntelliVue Information
Center Release N or later).
Integrated Smart-hopping radio. Integrated Short-Range Radio (SRR). Communication with IntelliVue Patient Monitors and Cableless
Measurements via Short-Range Radio connection (MP5/MP5T/MP5SC,
MP2 and X2 monitors only).
Powered by three AA batteries or rechargeable lithium-ion battery
pack.
Audio feedback for out-of-range and lost device. Battery gauge on device and at Information Center. Alarm suspend and resume from standby at device and Information
Center.
Pouch with clear front that closes securely.
Note — Unlike a traditional bedside monitor which operates on AC power,
the MX40 is powered by battery and provides time-limited screen display
and local alarming.
1-2 Introducing the IntelliVue MX40
MX40 Models
The MX40 is available in three models (ECG only, ECG and FAST SpO2, or
ECG and SpO2 Ready (for future upgrade).
Introducing the IntelliVue MX40 1-3
MX40 Compatibility
The MX40 is compatible for use with IntelliVue Information Center Release
N. Limited compatibility is offered when used with IntelliVue Information
Center Release L or M. See the "Operating with Release L or M" chapter for
more information.
The MX40 is compatible for use with IntelliVue Patient Monitors Release G
or later when wirelessly connected.
The MX40 is compatible for use with IntelliVue Cableless Measurements
Release A.1.
The MX40 is compatible for use with Access Point Controller 862147,
Release B.00.19 and Access Point Controller 865346, Release C.00.XX.
The MX40 Patient Cable is compatible for use with IntelliVue Patient
Monitor platforms MP2/X2, MP5/MP5T/MP5SC, MP20/30 with MMS or X2,
MP40/50 with MMS or X2, MP60/70 with MMS or X2, MP80/90 with MMS
or X2, and MX800/700/600 with MMS or X2.
1-4 Introducing the IntelliVue MX40
General Safety ............................................................................................ 2-2
Safety Symbols & Other Marks ............................................................... 2-4
2. Product Safety
This section consolidates the general safety warnings associated with the
IntelliVue MX40. These warnings are repeated throughout the book in
context where relevant.
Safety symbols and other markings on the MX40 are also described here.
Product Safety 2-1
General Safety
Warnings
The IntelliVue MX40 should not be used for primary monitoring in
applications where the momentary loss of the ECG is unacceptable at
the Information Center.
For continued safe use of this equipment, it is necessary that the listed
instructions are followed. Instructions in this manual in no way
supersede established medical procedures.
Do not touch the patient, or table, or instruments, during defibrillation.
The battery door must be closed during defibrillation. These steps
protect the clinician from high defibrillator voltage.
This device is not to be used in the vicinity of electrosurgical units
because such use may interrupt or interfere with the transmission of
signals from the MX40.
This equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air, or with oxygen or nitrous oxide.
This equipment is not suitable for use in an MRI environment. Do not use patient cables with detachable lead wires that have exposed
male pins. Electrocution could result if these pins are plugged into AC
power.
Do not use patient cables or accessory cables and sensors if prior visual
inspection reveals cable damage or the presence of liquid, lint or dust
inside.
The system is not completely immune from radio interference although
it is designed to minimize interference. Sources of interference that may
be a problem include failing fluorescent lights and construction
equipment. See "Electromagnetic Compatibility p. 13-6". The product
should not be used next to or stacked with other equipment. If you
must stack the product, you must check that normal operation is
possible in the necessary configuration before the product is used on
patients.
Do not rely exclusively on the audible alarm system for patient
monitoring. Adjustment of alarm volume to a low level during patient
monitoring may result in patient danger. Remember that the most
reliable method of patient monitoring combines close personal
surveillance with correct operation of monitoring equipment.
2-2 Product Safety
If the MX40 enters a continuous "boot-up" cycle or the main display
does not appear or update, ensure that you are using a freshly charged
lithium-ion battery or new disposable batteries. If the batteries are fresh
and the device reboots or does not update, remove the device from
service and contact your service personnel.
Place the MX40 in a pouch or over clothing, or both, during patient use.
The device should not touch the patient’s skin during use.
Patients should be instructed not to open the battery compartment
while the MX40 is in use.
Failure on the part of the responsible individual hospital or institution
employing the use of this equipment to implement satisfactory
maintenance as needed may cause undue equipment failure and
possible health hazards.
Because the coverage range of Access Points can sometimes overlap,
including different floor levels, the IntelliVue Device Location feature is
not intended for use when attempting to locate a patient.
Short-range radio connections are subject to interruption due to
interference from other radio sources in the vicinity, including
microwaves, bluetooth devices, and DECT phones. Outside the
frequency band and 5% above and below, i.e. the exclusion band
according to IEC 60601-1-2, the short-range radio connection is immune
up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending
on the strength and duration of the interference, the interruption may
occur for an extended period. Any interruption of the signal due to
interference, moving out of range, or for other reasons is indicated with
a Tele Disconnected INOP message on the IntelliVue Patient Monitor.
Caution
Philips recommends that when using a pouch to attach the MX40 to your
patient that you consider your patient's condition and are careful about
placement of the straps as the straps could present a strangulation hazard.
Product Safety 2-3
Label
Definition
FCC ID:
IC:
Federal Communications
Commission (FCC) ID
Canadian ID
Federal Communications
Commission (FCC)
Grant of Equipment Authorization
CE Mark (MX40)
Compliance to Council
Directive 93/42/EEC (Medical
Device Directive)
Class 2 Radio Equipment
Identifier (1999/5/EC)
CE Mark (Rechargeable Lithium-ion
Battery)
Compliance to Council Directive
2004/108/EC (EMC Directive)
Non-Ionizing Radiation
Interference to electronic equipment
may occur in the vicinity of devices
marked with this symbol.
Disposal
Dispose of in accordance with the
local country’s requirements.
Follow operating instructions.
Safety Symbols & Other Marks
The table below describes the safety symbols and other markings present on the MX40 and the
lithium-ion battery.
2-4 Product Safety
Label
Definition
Prescription Device
Canadian and American standards
compliance
Complies with applicable Canadian
and American safety standards.
Defibrillation Proof
Patient connections are protected
against defibrillation
(DEFIBRILLATION-PROOF) and are a
TYPE CF APPLIED PART.
Product Number
Serial Number
Used to identify the equipment during
a call to the Philips Healthcare
(Service).
MAC Address
Date of Manufacture
Battery Polarity
IPX Waterproof Rating
2D Barcode
Underwriter's Laboratories Listed
Component
Service Identification Number
Used to identify the equipment during
a call to Philips Healthcare (Service).
Product Safety 2-5
Label
Definition
Attention! See Instructions for Use.
2-6 Product Safety
Controls, Indicators and Connectors ...................................................... 3-2
Operating and Navigating ....................................................................... 3-8
Battery Information ................................................................................. 3-14
Pouch Use ................................................................................................. 3-22
Telemetry Mode Use ............................................................................... 3-26
Monitoring Mode Use ............................................................................. 3-27
Briefing the Patient .................................................................................. 3-28
3. Basic Operation
This section gives you an overview of the IntelliVue MX40 and its
functions. It tells you how to perform tasks that are common to all
measurements, such as turning a measurement on and off, adjusting wave
size and information in preparation for use.
Familiarize yourself with all instructions including warnings and cautions
before starting to monitor patients. Read and keep the Instructions for Use
that come with any accessories as these contain additional important
information.
Basic Operation 3-1
1. Patient Cable
2. Patient Information Area
3. Active Alarms Area
4. INOP Area
5. Measurement Area 1
6. Measurement Area 2
7. Waveform 1
8. Waveform 2
9. Radio/Network/Battery Status
Area
10. Leads Off Status Area
11. Silence Alarms Button
12. SmartKeys Button
13. Main Screen Button
14. Multi-Function Button
Controls, Indicators and Connectors
This section describes the clinical controls of the IntelliVue MX40. These
controls include buttons, display icons, visual and auditory indicators,
ports, and safety labeling located on the front and back of the device.
MX40 Controls and Indicators
3-2 Basic Operation
Button
Function
Depending on configuration at the Information
Center:
generates a Nurse Call;
Initiates a Delayed Recording;
Both, or;
None
Note —the Multi-Function Button does not operate
when paired with an IntelliVue Patient Monitor via
the short-range radio connection.
Button
Function
Initiates a local silence/acknowledgment of
all active alarms when enabled.
Silences the "Find Device" sound.
Note — Alarms at the MX40 can be silenced
from the Information Center.
Button
Function
Displays the SmartKey Menu on the touch
screen.
Multi-Function Button
Silence Alarm Button
SmartKeys Button
Basic Operation 3-3
Button
Function
Activates the Touch Display if touched for two
seconds.
Cycles through the display screens if touched
repeatedly.
Resumes from Standby.
SmartKey
Function
Start SpO2
Note — This
SmartKey is
unavailable
when SpO2
mode is
continuous.
Starts a manual SpO2 measurement.
Delay Record
Starts a delayed recording at the
Information Center.
Alarms
Review of up to 50 previous alarm
conditions (entries are stored during
power cycle). Pause Alarms for
configured time period (if enabled at
the Information Center).
Mode:
Telemetry /
Mode: Monitor
Toggles between modes. In
Telemetry Mode, display and audio
are off; in Monitor Mode, display and
audio are always on.
Main Screen Button
SmartKeys
The following table lists the SmartKeys available on the display of the
MX40.
Note—gray text on a SmartKey signifies that the item is unavailable.
3-4 Basic Operation
SmartKey
Function
Standby
Puts the device into standby locally
and at the Information Center.
Displays purchased/enabled product
options.
Add/Remove
Displays available monitors and
IntelliVue Cableless Measurements
to assign to via the short-range radio.
Print Reports
Prints the pre-configured report as
designated at the Information Center.
Vitals Trends
(Optional)
View up to 24 hours of tabular trend
data.
Screen Setup
Determines time period that the
display remains active after user
interaction.
Lock/Unlock
Locks/Unlocks the display.
Op Mode
Selects either Monitoring, Demo,
Config or Service modes.
The Alarm Area of the MX40 displays
physiological alarms and technical alarms.
A multiple alarm indicator (down arrow) is
displayed when multiple alarm conditions
are present.
A check mark in front of the alarm text
signifies that the alarm has been
acknowledged by touching the Silence
Alarms button.
Alarm Indicators display in the Patient
Information Area in place of the time clock
when alarm/INOP conditions are present
but have not been acknowledged.
Touching the Alarms Area displays a list of
all active alarms.
The alarms paused icon communicates
whether the alarm system is on/off.
Local Alarm Audio is off when the alarm
volume symbol is present.
Alarms Area
Basic Operation 3-5
The Patient Information Area displays the following information:
Bed Label
Patient Name (up to 15 characters will display)
Time
Touching the Patient Information Area displays the Patient Demogr. menu which lists
the following:
Patient Name (Last, First, Middle)
Lifetime ID
Encounter ID
Patient Category
Paced Mode
Height
Weight
Date of Birth
Gender
Note — If you use an alternative ID, it will display at the Information Center and on
printed reports. It will not display at the MX40.
1. Pacing algorithm is on.
2. Pacing algorithm is off.
Patient Information Area
Paced Status
3-6 Basic Operation
The Lock symbol appears in the lower left of the display when
the MX40 is in a locked state after five minutes of non-use.
Locking the display provides additional protection against
accidental patient access. The display is unlocked using the
SmartKeys menu.
The status area of the MX40 displays short-range radio
connection (optional) and system wireless connection
status. You can also view battery strength for the type
of battery used in the device, AA or rechargeable
Li-on.
Display Lock
Status Area
Basic Operation 3-7
Operating and Navigating
The principle method of operating your MX40 is via the Touch Display.
Almost every element on the display is interactive. Display elements
include measurement numerics, information fields, alarm fields,
waveforms, SmartKeys and menus.
Power-On Self Test
Once battery power is supplied, the MX40 performs a power-on self test to
check operational status prior to start-up. Should a failure be detected, an
INOP tone will sound and if possible, the appropriate INOP message for
the failure will be communicated to the Information Center and displayed
locally.
A successful power-on self test will then transition the MX40 to the start-up
screen. Selectable background colors can be configured and display on the
screen for assistance with device identification. This can be helpful when
devices are in a pooled use setting.
If the MX40 enters a continuous "boot-up" cycle or the main display does
not appear or update, ensure that you are using a freshly charged
lithium-ion battery or new disposable batteries. If the batteries are fresh and
the device reboots or does not update, remove the device from service and
contact your service personnel.
You must visually check that a waveform is present on the display. You can
access further status information is by touching the status area on the
display.
Navigating
Touching the Navigation Bar on the right of the display will scroll through
additional display items. Solid downward arrows indicate there are
additional elements that are not currently displayed. The arrows briefly
illuminate when touched. Your selection from the menu also illuminates
when touched.
3-8 Basic Operation
Function
Display
Locked/Active
Display
Locked/Inactive
Display
Unlocked/Active
Display
Unlocked/Inactive
Display Touch
No
No
Yes
No
Main Screen
Button
No
Yes
Yes
Yes
SmartKeys Button
Yes
No
Yes
No
Silence Button
No
No
Yes
No
Selecting Display Elements
Touch a display element to get to the actions linked to that element. For
example, touch the Patient Information element to call up the Patient Info
window, or touch the HR numeric to call up the Setup ECG menu. Touch
the ECG waveform to call up the wave selection menu.
Locking the Display
To provide additional protection against accidental patient access to the
MX40, the display can be locked using the Lock SmartKey. When Lock is
selected, the SmartKey menu automatically changes to the Main Screen.
When Unlock is selected, you must close the SmartKey menu to return to
the Main Screen.
The display automatically locks when there is no interaction for five
minutes.
Measurement Area
The measurement area of the MX40 display is optimized to show available
parameter numerics, waveforms, and alarm limits. Each element is a touch
object and when you select it, further controls and menus become available.
Basic Operation 3-9
Measurement Area Display Configurations
The display of your MX40 is configured/can operate in one of four available
orientations:
Portrait - One Waveform and four Numerics Portrait - Two Waveforms and two Numerics (IIC Release N only) Landscape - Two Waveforms and three Numerics (IIC Release N only) Portrait - Viewable Chest Diagram and two Numerics
Connecting/Disconnecting the Patient Cable
The patient cable is connected to the MX40 as shown in the illustration
below.
When connecting to the MX40, there is a slight clicking sound that signifies
that the cable is securely connected.
3-10 Basic Operation
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